PALO
ALTO, Calif., May 13, 2024
/PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a
biopharmaceutical company committed to researching, developing and
commercializing transformative therapeutics to treat a broad
spectrum of retinal diseases, announced today that the first
patients with diabetic retinopathy (DR) have been treated in the
randomized double masked Phase 3 GLOW2 study of tarcocimab
tedromer.
GLOW2 is the second Phase 3 study of tarcocimab in diabetic
retinopathy in which all patients on investigational therapy will
receive tarcocimab on extended dosing intervals, including 6-month
dosing for all patients. The GLOW2 study design mirrors the
successful GLOW1 study in which tarcocimab-treated patients, over
the 48-week study duration, saw 29-fold increased response rate in
≥ 2-step improvement in DRSS (treatment) and 89% decreased risk of
developing sight-threatening complications (prevention).
Consistent with Kodiak's operational track record of running six
pivotal studies in parallel for the tarcocimab program, GLOW2 is on
an accelerating trajectory of site activations, new patient
screenings and randomizations with the goal to complete enrollment
before the end of this year.
"In recent months, competing long-acting retinal therapies in
development have posted disappointing treatment and prevention
results in diabetic retinopathy," said Dr. Victor Perlroth, Kodiak's Chief Executive
Officer. "GLOW1 data showed unequivocally that treatment with
tarcocimab in extended dosing intervals including 6-month dosing in
all patients achieved two related but clinically distinct goals:
treating existing disease (primary endpoint of 2-step
improvement in DRSS) and preventing disease progression (key
secondary endpoint of preventing sight-threatening complications).
This is a key differentiator in the long-acting therapy space,
where many therapies are only designed to maintain a patient's
current disease status and not to improve it."
If successful, GLOW2 could serve as one of the two successful
pivotal studies in one foundational indication, diabetic
retinopathy, to support marketing authorization application for
tarcocimab.
About the Phase 3 GLOW2 Study
The Phase 3 GLOW2 study is a prospective, randomized,
double-masked, multi-center pivotal superiority study designed to
evaluate the efficacy and safety of tarcocimab tedromer in
treatment-naïve patients with diabetic retinopathy (DR). Patients
are randomized 1:1 and receive tarcocimab via intravitreal
injection at baseline, Week 4, Week 8, Week 20 and Week 44. The
primary endpoint is the proportion of eyes improving ≥2 steps on
Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week
48. Additional outcome measures include the proportion of eyes
developing a sight threatening complication of diabetic retinopathy
and the proportion of eyes improving ≥3 steps on DRSS from baseline
at Week 48. Additional information about GLOW2 (also called Study
KS301P108) can be found on www.clinicaltrials.gov under Trial
Identifier NCT06270836
(https://clinicaltrials.gov/show/NCT06270836).
About tarcocimab tedromer (tarcocimab, KSI-301)
Tarcocimab is an investigational anti-VEGF therapy built on
Kodiak's proprietary Antibody Biopolymer Conjugate ("ABC") Platform
and is designed to maintain potent and effective drug levels in
ocular tissues for longer than existing available agents. Kodiak's
objective with tarcocimab is to enable earlier treatment and
prevention of vision loss for patients with diabetic retinopathy
and to develop a new durability agent to improve outcomes for
patients with retinal vascular diseases.
To date, tarcocimab has completed three successful Phase 3
pivotal clinical studies: the Phase 3 GLOW1 study in diabetic
retinopathy ("DR"), the Phase 3 BEACON study in retinal vein
occlusion ("RVO") and the Phase 3 DAYLIGHT study in wet AMD. Across
the full tarcocimab pivotal program of six Phase 3 studies,
tarcocimab has demonstrated what Kodiak believes to be consistent
durability of approximately 6 months for the majority of patients
and favorable safety.
Kodiak is initiating two additional BLA-facing Phase 3 studies:
the GLOW2 study in diabetic retinopathy, and the DAYBREAK study in
wet AMD. The GLOW2 study has a similar design as GLOW1 with the
benefit of an additional, third monthly loading dose (weeks 0, 4
and 8). The DAYBREAK study will include investigational arms for
tarcocimab and KSI-501, Kodiak's bispecific conjugate, to evaluate
their efficacy, safety and durability versus aflibercept. DAYBREAK
is designed to strengthen the competitive position of tarcocimab in
wet AMD and bolster the ex-US regulatory dossier for the program.
Both GLOW2 and DAYBREAK will use a go-to-market formulation of
tarcocimab which we believe improves the manufacturability in a
prefilled syringe and may also enhance the utility of the
product. GLOW2 is actively enrolling patients, and we are
operationalizing towards DAYBREAK study activation in mid-2024.
About Kodiak Sciences Inc.
Kodiak Sciences (Nasdaq: KOD) is a biopharmaceutical company
committed to researching, developing, and commercializing
transformative therapeutics to treat a broad spectrum of retinal
diseases. We are focused on bringing new science to the design and
manufacture of next generation retinal medicines to prevent and
treat the leading causes of blindness globally. Our ABC Platform™
uses molecular engineering to merge the fields of protein-based and
chemistry-based therapies and has been at the core of Kodiak's
discovery engine. We are developing a portfolio of three clinical
programs, two of which are late-stage today and derived from our
ABC Platform and one which is platform-independent and which we
believe can progress rapidly into pivotal studies.
Kodiak's lead investigational medicine, tarcocimab, is a novel
anti-VEGF antibody biopolymer conjugate under development for the
treatment of high prevalence retinal vascular diseases including
diabetic retinopathy, the leading cause of blindness in working-age
patients in the developed world, and wet age-related macular
degeneration, the leading cause of blindness in elderly patients in
the developed world.
KSI-501 is our second investigational medicine, a first-in-class
anti-IL-6, VEGF-trap bispecific antibody biopolymer conjugate
designed to inhibit both IL-6 mediated inflammation and
VEGF-mediated angiogenesis and vascular permeability. KSI-501 is
being developed for the treatment of high prevalence retinal
vascular diseases to address the unmet needs of extended durability
and targeting multiple disease biologies for differentiated
efficacy. Phase 1b data for KSI-501
was presented in February 2024, and
the Phase 3 DAYBREAK study of KSI-501 in wet AMD is scheduled to be
actively screening patients in mid-2024.
Additionally, Kodiak is developing a third product candidate,
KSI-101, a novel anti-IL-6, VEGF-trap bispecific protein, the
unconjugated protein portion of KSI-501. Kodiak intends to develop
KSI-101 for the treatment of retinal inflammatory diseases, as
currently there are no available intravitreal biologic therapies
addressing the spectrum of inflammatory conditions of the
retina.
Kodiak has expanded its early research pipeline of duet and
triplet inhibitors that embed small molecules and other active
pharmaceutical ingredients ("API") in the biopolymer backbone to
enable targeted, high drug-antibody ratio ("DAR") medicines. The
diverse API's are designed to be released over time to achieve
sustained modulation of targeted biological pathways. The unique
combination of high DAR and tailored therapeutic benefit offers
potential for broad application to multifactorial ophthalmic and
systemic diseases.
For more information, please visit www.kodiak.com.
Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak
logo are registered trademarks or trademarks of Kodiak Sciences
Inc. in various global jurisdictions.
Forward-Looking Statements
This release contains "forward-looking statements" within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
not based on historical fact and include statements regarding:
GLOW2's trajectory of site activations, new patient screenings
and randomizations with the goal to complete enrollment before the
end of this year, the potential for GLOW2 to serve as one of the
two successful pivotal studies in one foundational indication,
diabetic retinopathy, to support marketing authorization
application for tarcocimab, future development plans and the
expected timing of clinical study readouts; the objectives and
potential benefits of KSI-501, including its potential to be a
first-in-class bispecific ABC inhibiting VEGF and IL-6 and its
potential to provide extended durability; and the objectives of our
tarcocimab clinical program. Forward-looking statements generally
include statements that are predictive in nature and depend upon or
refer to future events or conditions, and include words such as
"may," "will," "should," "would," "could," "expect," "plan,"
"believe," "intend," "pursue," and other similar expressions among
others. Any forward-looking statements are based on management's
current expectations of future events and are subject to risks and
uncertainties that could cause actual results to differ materially
and adversely from those in or implied by such forward-looking
statements. These risks and uncertainties include, but are not
limited to: cessation or delay of any clinical studies and/or
development of KSI-501 may occur; the risk that KSI-501 may not
inhibit VEGF and IL-6, provide extended durability or have an
impact on the treatment of patients as expected; adverse economic
conditions may significantly impact our business and operations,
including our clinical trial sites, and those of our manufacturers,
contract research organizations or others with whom we conduct
business; as well as the other risks identified in our filings with
the Securities and Exchange Commission (SEC). For a discussion of
other risks and uncertainties, and other important factors, any of
which could cause our actual results to differ from those contained
in the forward-looking statements, see the section entitled "Risk
Factors" in our most recent Form 10-K, as well as discussions of
potential risks, uncertainties, and other important factors in our
subsequent filings with the SEC. These forward-looking statements
speak only as of the date hereof and Kodiak undertakes no
obligation to update forward-looking statements, and readers are
cautioned not to place undue reliance on such forward-looking
statements. Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the
Kodiak logo are registered trademarks or trademarks of Kodiak
Sciences Inc. in various global jurisdictions.
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SOURCE Kodiak Sciences Inc.